A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 110
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.
详细描述
This study will be a randomised, double-blind, placebo-controlled, dose-escalation, single and multiple oral dose study conducted in 2 parts.
In Part A, each subject will participate in 1 treatment period only and reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours postdose), except for Group A4, where each subject will participate in 2 treatment periods separated by a minimum of 13 days to evaluate the effect of food.
In Part B, each subject will participate in 1 treatment period only and reside at the CRU from Day -1 (1 day before dosing) until the morning of Day 9 (48 hours after the final dose on Day 7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.0 and 32.0 kg/m2
- •Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
排除标准
- •Subjects who do not agree to use a method of acceptable contraception
- •Female subjects of child-bearing potential who do not agree to use a highly effective method of birth control
- •Consume more than 28 or 21 units of alcohol per week if male or female, respective
- •Subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration
- •Subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration
- •Systolic blood pressure < 90 mmHg or > 140 mmHg
- •Diastolic blood pressure < 50 mmHg or > 90 mmHg
- •Pulse rate < 45 bpm or > 100 bpm
- •Positive urine drugs of abuse screen at screening or first admission
- •Positive alcohol breath test at screening or first admission
- •Positive cotinine test at screening or first admission
- •Abnormality in the 12-lead ECG at screening, admission or predose on Day 1
- •Subjects who are pregnant, breastfeeding, or lactating
- •Subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of any investigational drug in the past 3 months prior to the first dose administration
- •Subjects who have a significant history of drug allergy, as determined by the Investigator
- •Aspartate aminotransferase and/or Alanine aminotransferase ≥ 1.5 × upper limit of normal (ULN) or total bilirubin > ULN at screening or admission
- •Subjects who are carriers of HBsAg or hepatitis C antibody, have serum hepatitis or positive result for the test for HIV antibodies
研究组 & 干预措施
Active in Group A1~A7
In each of Groups A1 to A7, 8 subjects will receive DA-8010.
干预措施: DA-8010 (Drug)
Placebo in Group A1~A7
In each of Groups A1 to A7, 2 subjects will receive placebo.
干预措施: Placebo (Drug)
Active in Group B1~B4
In each of Groups B1 to B4, 8 subjects will receive DA-8010.
干预措施: DA-8010 (Drug)
Placebo in Group B1~B4
In each of Groups B1 to B4, 2 subjects will receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: during 16 days in Part B
Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).
次要结局
- Area under the plasma concentration-time curve (AUC)(48 hours)
- Maximum observed plasma concentration (Cmax)(48 hours)
- Time of the maximum observed plasma concentration (tmax)(48 hours)